Bioequivalence: Some relevant clinical and biopharmaceutic aspects

Francisco J. Flores-Murrieta, Miriam Del C. Carrasco-Portugal, Héctor León-Molina, Miguel Luján

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Evaluation of bioequivalence is mandatory in order to establish interchangeability of generic drugs. Although there are several factors that may influence the bioavailability of drugs after oral administration, special attention has received solubility and permeability. In fact, drugs have been classified in four groups depending on them. In general, it has been established that biowaiver can be given to BCS class I drugs (high permeability, high solubility) since absorption of this kind of drugs is not importantly affected. There is controversy about class III drugs (high solubility, low permeability), since FDA does not give biowaiver, whereas, WHO establish that biowaiver may be given. Class II and IV require bioequivalence studies. In order to contribute to a harmonization, several examples for different kind of drugs, in which dissolution profile and comparative bioavailability were evaluated, are presented in this chapter. In general, for oral administered drugs, bioequivalence allows us to warrant that interchangeability is possible. However, in the case of drugs that are intended for site effect administration, such as inhaled suspensions, measurement of plasma levels does not warrant the therapeutic equivalence. In such cases, measurement of the effect is a good approach to demonstrate the interchangeability. Results about studies carried out with this kind of drugs are given and the clinical relevance of this kind of studies is provided. All data provided in this chapter allow us to conclude that research focused to improve regulation in bioequivalence will contribute to a better quality of generic drugs. © 2010 Nova Science Publishers, Inc. All rights reserved.
Original languageAmerican English
Title of host publicationBiopharmaceutics and Drug Hypersensitivity
Number of pages4
ISBN (Electronic)9781607418306
StatePublished - 1 Dec 2010

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Flores-Murrieta, F. J., Carrasco-Portugal, M. D. C., León-Molina, H., & Luján, M. (2010). Bioequivalence: Some relevant clinical and biopharmaceutic aspects. In Biopharmaceutics and Drug Hypersensitivity